Identity
- Trade Name
- REMEL FDA UDI
- Generic Name
- Acid-alcohol solution IVD FDA UDI
- Device Name
- TB Decolorizer (3% acid alc) BTLx5/250ml FDA UDI
- Model / Reference
- R40206 FDA UDI
- Description
- TB Decolorizer (3% acid alc) BTLx5/250ml FDA UDI
Identifiers
- Catalog Number
- R40206 FDA UDI
- Primary DI / UDI-DI
- 00848838065972 FDA UDI
- FDA Product Code
- PPM FDA UDI
- GMDN Term
- Acid-alcohol solution IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.4010 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Acid-alcohol solution IVD
Remel by Remel, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Acid-alcohol solution IVD.
- REMEL — REMEL, INC. · Class I
- REMEL — REMEL, INC. · Class I
- REMEL — REMEL, INC. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Remel, Inc.
Sources (1)
- FDA UDI 2bf211c5-1c3e-480a-8830-f8f990ba5e46 34 fields · synced Jun 8, 2026